Single Tooth LostNCT05295082
Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement
A study testing guided trephination-based drilling protocol and guided Conventional drilling-based protocol in people with Single Tooth Lost and Partially Edentulous Maxilla, run by Mohammed Ramadan at 1 site in Egypt.
Trial summary
This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Tooth Lost, Partially Edentulous Maxilla
- What is being tested?
- guided trephination-based drilling protocol and guided Conventional drilling-based protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single missing maxillary premolar or molar tooth.
- Both genders aged from 20-50 years.
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire. (Pendleton et al,.2004)
- Mesio-distal space ≥ 7 mm.
- Bone width in bucco-lingual direction ≥ 6 mm.
- Uniform alveolar ridge with no undercuts.
Show all 9Show fewer
- Present mesial and distal sound neighboring teeth.
- At least 4 natural remaining teeth on the same arch.
- Mouth opening at least 30 mm.
Who cannot join
- 1) Pregnant and lactating females. 2) Smokers. 3) Poor oral hygiene. 4) Vulnerable groups of patients' e.g. (handicapped patients).
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study
This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
Read the detailed description
This study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (CBCT ) will be performed to compare the virtual implant position and the actual implant position.
- Conditions
- Single Tooth Lost, Partially Edentulous Maxilla
- Being tested
- guided trephination-based drilling protocol, guided Conventional drilling-based protocol
- Keywords
- guided implant, surgical guide, dental implant, dental trephination, guided trephination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided trephination-based drilling protocolProcedure or surgery
the implant site preparation in this group will be done by guided trephination protocol which uses the surgical guide to trephine the implant site then remove the guide and continue the drilling in a freehand manner
guided Conventional drilling-based protocolProcedure or surgery
the implant site preparation in this group will be done by a guided conventional drilling protocol which uses the surgical guide to guide the sequential drills up to the final drill
| Study group | Role | What they receive |
|---|---|---|
| guided trephination-based protocol | Experimental | The drilling process will be performed by guided trephination protocol.
* An appropriate trephine drill (Helmut Zepf Medizintechnik GmbH, Germany) will be used to create an initial osteotomy.
* The guide will be removed, and the depth and angulation of this initial osteotomy will be evaluated.
* The final drill of the chosen implant system will be used to complete the osteotomy.
* The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner. Receives: Procedure: guided trephination-based drilling protocol |
| guided conventional drilling-based protocol | Active comparator | The drilling process will be performed by a guided conventional drilling protocol.
* Drilling (Neo NaviGuide System - Neobiotech Co. Ltd. Korea) will be performed throughout the guiding sleeve from the first drill to the final drill.
* The guide will be removed.
* The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner. Receives: Procedure: guided Conventional drilling-based protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal deviation at apex of the implant.
measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position
Measured: immediately after the intervention
•Horizontal deviation at implant shoulder.
measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position
Measured: immediately after the intervention
Angular deviation.
measure the Angular deviation of the implant between the virtual planning position and the actual implant position
Measured: immediately after the intervention
Secondary outcomes (2)
The duration of the surgery
measure the time of the surgery from the first drill to the implant placement
Measured: during the surgery
Satisfaction assessed by the Visual Analogue Scale
measure the patient satisfaction score on terms of pain and discomfort from 1 to 10
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Apr 2022
- Primary completion20 Jun 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Single Tooth LostStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- guided dental implant placement through guided trephine-based implant site preparation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Ramadan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Ramadan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295082
- Sponsor's protocol ID
- FDASU-RecIM012225
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data that will be shared is the CBCT, virtual planning
Publications
Suriyan N, Sarinnaphakorn L, Deeb GR, Bencharit S. Trephination-based, guided surgical implant placement: A clinical study. J Prosthet Dent. 2019 Mar;121(3):411-416. doi: 10.1016/j.prosdent.2018.06.004. Epub 2018 Nov 30.
PubMed 30503150Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
PubMed 23062136Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Accuracy of a computer-aided implant surgical technique. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):317-25. doi: 10.11607/prd.1019.
PubMed 23593625
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05295082
- Acronym / sponsor ID
- FDASU-RecIM012225
- Conditions
- Single Tooth Lost, Partially Edentulous Maxilla
- Keywords
- guided implant, surgical guide, dental implant, dental trephination, guided trephination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mohammed RamadanUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
Detailed description
This study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (CBCT ) will be performed to compare the virtual implant position and the actual implant position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- guided dental implant placement through guided trephine-based implant site preparation
| Arm | Type | Receives |
|---|---|---|
| guided trephination-based protocol | Experimental | Procedure: guided trephination-based drilling protocolThe drilling process will be performed by guided trephination protocol. * An appropriate trephine drill (Helmut Zepf Medizintechnik GmbH, Germany) will be used to create an initial osteotomy. * The guide will be removed, and the depth and angulation of this initial osteotomy will be evaluated. * The final drill of the chosen implant system will be used to complete the osteotomy. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner. |
| guided conventional drilling-based protocol | Active comparator | Procedure: guided Conventional drilling-based protocolThe drilling process will be performed by a guided conventional drilling protocol. * Drilling (Neo NaviGuide System - Neobiotech Co. Ltd. Korea) will be performed throughout the guiding sleeve from the first drill to the final drill. * The guide will be removed. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Single missing maxillary premolar or molar tooth.
- Both genders aged from 20-50 years.
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire. (Pendleton et al,.2004)
- Mesio-distal space ≥ 7 mm.
- Bone width in bucco-lingual direction ≥ 6 mm.
Key exclusion criteria (2 listed)
- 1) Pregnant and lactating females. 2) Smokers. 3) Poor oral hygiene. 4) Vulnerable groups of patients' e.g. (handicapped patients).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided trephination-based drilling protocolthe implant site preparation in this group will be done by guided trephination protocol which uses the surgical guide to trephine the implant site then remove the guide and continue the drilling in a freehand manner | Procedure or surgery | guided trephination-based protocol |
| guided Conventional drilling-based protocolthe implant site preparation in this group will be done by a guided conventional drilling protocol which uses the surgical guide to guide the sequential drills up to the final drill | Procedure or surgery | guided conventional drilling-based protocol |
Primary outcome
Horizontal deviation at apex of the implant.
Time frame: immediately after the intervention
measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position
•Horizontal deviation at implant shoulder.
Time frame: immediately after the intervention
measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position
Angular deviation.
Time frame: immediately after the intervention
measure the Angular deviation of the implant between the virtual planning position and the actual implant position
2 secondary outcomes
The duration of the surgery
Time frame: during the surgery
Satisfaction assessed by the Visual Analogue Scale
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Results publication: PubMed 30503150Suriyan N, Sarinnaphakorn L, Deeb GR, Bencharit S. Trephination-based, guided surgical implant placement: A clinical study. J Prosthet Dent. 2019 Mar;121(3):411-416. doi: 10.1016/j.prosdent.2018.06.004. Epub 2018 Nov 30.
- Results publication: PubMed 23062136Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
- Results publication: PubMed 23593625Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Accuracy of a computer-aided implant surgical technique. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):317-25. doi: 10.11607/prd.1019.
- Individual participant dataSharing planned: No. the data that will be shared is the CBCT, virtual planning
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided trephination-based drilling protocol and guided Conventional drilling-based protocol in people with Single Tooth Lost and Partially Edentulous Maxilla, run by Mohammed Ramadan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal deviation at apex of the implant. (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.